B. Annex: Data sharing checklist

This section summarises in a comprehensive table all the actions to be performed in the case of Data Holders that will deploy a federated node.

Initial Assessment

Action
Description
Documents

Submit an application for data incorporation use cases.

Complete the application for data incorporation use cases form for the Access Committee to evaluate the scientific relevance of your participation in EUCAIM as a data holder.

Complete the TIERs maturity level questionnaire.

Complete it to assess the readiness and compliance of your datasets and categorize them according to their maturity level (TIER 1, 2, or 3).

Complete the DW maturity level questionnaire (only for clinical sites, as hospitals)

Complete it to determine the current state of the hospital's Data Warehouse preparedness and maturity.

Action
Description
Documents

Provide documentation

  • Proof of legal representation and legal basis if necessary.

  • A copy of a favorable ethical approval (if applicable).

  • A report from the DPO confirming legal compliance.

  • GDPR compliance.

  • Data Protection Impact Assessment (DPIA), if applicable.

  • Documents demonstrating the security of the information system.

  • Any documents required under your national legislation.

  • Evidence of an adequate anonymization/pseudonymization process that has been carried out.

  • Terms of Usage for the data.

D4.4 Final rules for participation reportarrow-up-right (See Sections 4.4.1 (Legal requirements) and 4.4.2 (Ethical requirements for Data Holders)

Data Sharing Agreement

Fill-in and sign the DSA

Define especial Access Conditions

A Document to be signed by the Data User that indicates the conditions under the Data User can access the data.

Preliminaries

Action
Description
Documents

Contact point for the negotiation (Only in federated nodes)

The LS-AAl details of the data holder delegate who will interact with the Data User through the negotiator.

Local Node (T1/2)

Action
Description
Documents

Setup your local node

Deploy a node to host data and services to reach the desired interoperability level.

Set up of the local catalogue (optional)

Deployment of a local instance of the catalogue.

Request a EUCAIM User

Request a EUCAIM User in the Dashboard.

Data Preparation

Action
Description
Documents

Extract the Imaging and clinical data

Use your own tools to extract the Medical Images and the clinical data

N/A

Annotate the data (optional)

Use your own annotation tool or the one selected by EUCAIM (MITK). Convert the annotations into DICOM-SEG.

Data de-identification

Ensure that no identifiable information is present in the dataset. If your imaging data are not already de-identified, you may use the EUCAIM Anonymizer.

Re-identification risk assessment (optional)

Assess the risk of re-identification of patients based on your imaging metadata by checking hidden DICOM Tags.

Data Quality assessment (optional)

You may check the accuracy and integrity of your imaging dataset.

Catalogue Population

Action
Description
Documents

Create local catalogue (optional)

Data should follow the EUCAIM interoperability schema.

Make a request for catalogue registration

Create a helpdesk ticket on the category catalogue, providing the link to the dataset in the local catalogue, if available, or the completed catalogue metadata spreadsheet. The helpdesk team will contact you back informing if the dataset has been properly registered or requesting more information.

Action
Description
Documents

Definition of Mapping to CDM Template (optional)

A mapping template of the mandatory and other significant attributes to the CDM should be defined.

ETL process

The ETL tool should be applied to map the clinical and imaging data to the CDM.

Development of Mediator Component (optional)

Develop a mediator to connect the local searching API with the federated explorer.

Section 5.2.1 Dataset in a Federated Node. subsection "Guidelines for creating a mapping component" in D5.6

Deployment of search components.

Deploy the Beam Proxy and the Focus query dispatcher.

Federated Processing

Action
Description
Documents

Request registration in the federated explorer

Request the connection of the central instance of the federated search through a ticket in the helpdesk.

Deployment of the FEM client Deploy a federated computing node

Deploy the container to run the service to interact with the federated processing. Request technical support to the technical team through the helpdesk.

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